A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

NCT05635747 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: P00042824
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition. Goal of the observational study is to determine safety and tolerability of Relizorb Enzyme Cartridge for an additional 90 days after the original trial

Conditions

Short Bowel Syndrome; Malabsorption

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days

  change from baseline in PN calories

  90 days

Secondary Outcomes (1)

• To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days

  90 days

Study Arms (1)

Patients who have completed the Relizorb Trial and consented into the 90 day extension trial

Patients aged 2-18 who have completed the 90 day open label phase 3 Relizorb trial who consent to the 90 day observational Relizorb extension trial

Device: Relizorb Enzyme Cartridge

Interventions

Relizorb Enzyme Cartridge DEVICE

Tube feeds run across device to digest fats.

Patients who have completed the Relizorb Trial and consented into the 90 day extension trial

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 32 pediatric subjects with SBS, aged 2 years - 18 years who are PN dependent are expected to be enrolled in the ongoing clinical study and will be invited to participate in this extension study. Eligibility will be established by the investigator based on the inclusion and exclusion criteria for the extension study.

You may qualify if:

• Patient is currently enrolled in the ongoing RELiZORB study titled "A 90 day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children with Short Bowel Syndrome who are Dependent on Parenteral Nutrition"
• The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
• The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study-related procedures (as determined by the investigator).
• A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.

You may not qualify if:

• Active clinically-significant pancreatic or biliary disease, as determined by the investigator.
• Change in patient formula such that the new formula is not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
• Determined by the investigator to be unsuitable for participation for any reason.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Alcresta Therapeutics, Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.

  PMID: 28471913 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark Puder, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor Pediatric General Surgery

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)